Health Weekly: Stop hiding negative clinical data, IOM urges

In the face of estimates that at least half of clinical trials data never see the light of day because of negative or undesirable findings, the prestigious U.S. Institute of Medicine (IOM) issued a preliminary report urging that such adverse information be made publicly available within a year of a trial’s completion.

Arguing that greater data sharing “could enhance public well-being by accelerating the drug discov­ery and development process, reducing redundant research, and facilitating scientific innovation,” an IOM panel urges in a report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, that the sharing of clinical trials data become the “expected norm” of the industry.

Among recommendations is that investigators be obliged to outline data-sharing plans when their clinical trials are registered, that summary results from a trial, including information about adverse events, be made public within a year of a trial’s completion, and a “full analyzable data set with metadata” be made available within 18 months.

“Responsible sharing of clinical trial data will allow other investigators to carry out additional analyses and reproduce publishing findings, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators,” argued the IOM panel chaired by Greenwall Foundation President Bernard Lo.

The much-anticipated report is viewed as the basis upon which some manner of framework can be established to begin to lift the shroud of secrecy surrounding trials data that is typically undisclosed until firms are forced to do so by the courts, a level of secrecy that has often compromised public trust in the reliability of medical evidence. While the report urges a new data-sharing paradigm for future public trials, it is silent on the data from past clinical trials. Industry has long argued greater data-sharing will compromise confidential commercial considerations.

Canada desperately needs to update its national AIDS strategy so that it can achieve UNAIDS’ 90-90-90 target for 2020, which aims to have 90 per cent of HIV individuals diagnosed, 90 per cent to receive antiretroviral therapy, and 90 per cent to achieve sustained viral suppression, Dr. Julio Montaner, director of the British Columbia Centre for Excellence in HIV/AIDS and past-president of the International AIDS Society argued in a Huffington Post column. “We urgently need to emulate the BC TasP [Treatment as Prevention] program across Canada by expanding access to HIV testing (including HIV screening), and liberalizing and facilitating free access to HAART [highly active antiretroviral therapy], care and support. We need stronger anti-discrimination legislation that protects those infected and those most at risk for acquisition of HIV infection. We must repel federal law criminalizing HIV exposure and introduce new laws that truly protect the safety of sex workers. We must promote access to addiction therapy, and as needed, facilitate access to harm reduction (including supervised consumption and medicalized access to heroin). Last and not least, we need to engage with most at-risk populations, including Aboriginal communities (on and off Reserves) to better understand how to culturally adapt access to services.”

The health lobby was the most active of all sectors in November, 2014, representing 376 of 1,871 communications reported in the Office of the Commissioner of Lobbying’s online registry. “While the organizations lobbying and their asks are varied, there is a coordinated effort from a coalition of at least 30 health organizations, led by the Canadian Medical Association, to draft a national seniors’ care plan and have the federal parties endorse it,” the Hill Times reported.

Canada will deploy a third mobile laboratory and two additional scientists to Sierra Leone as part of its contribution to the global effort to contain the Ebola outbreak in West Africa.

From the provinces:

Newfoundland needs a “change in approach” to primary health care if it’s constrain costs that now gobble up 40 per cent of the province’s budget, Conservative Premier Paul Davis told his one-day summit on health care reform.

Among findings from the regional consultations were that “coordination and continuity of care are perceived to be lacking in Newfoundland and Labrador and more needs to be done to recruit providers who will stay in the communities where they are needed,” and that “rushed visits reduce access to primary health care. Overall, a fee-for-service compensation scheme was viewed as costly and unconducive to encouraging holistic multidisciplinary care.”

Québec Medical Association President Laurent Marcoux says the province’s doctors are willing to consider alternate forms of payment to fee-for-service if it helps to resolve the ongoing battle over Bill 20, which will require physicians to assume responsibility for 1,000 patients or lose 30 per cent of their pay, and which has resulted in nasty exchanges, including accusations by Health Minister Gaetan Barrette that 60 per cent the province’s physicians are lazy part-timers who work less than 25 weeks per year. “In Canada, Québec is the province where physician compensation is the most linked to fee-for-service payment. In the other provinces, the use of a mix of compensation methods made it possible to introduce the concept of population-based responsibility, which greatly contributed to improving access to health care services, especially primary care,” Marcoux wrote in a letter to the editor. “The QMA sincerely believes that physicians in Québec are ready for an open discussion on compensation methods, for the greater good of Québec’s citizens. As long as they have a say in the issue and are not seen as the problem, but as part of the solution.”

British Columbia’s Northern Health authority announced that it was notifying patients who received colonoscopies, upper gastric scopes and other procedures utilizing flexible endoscopes at the University Hospital of Northern B.C. between 2012 and December 2014 were at risk of infection because the devices weren’t properly cleaned. “Northern Health apologizes to the patients for any anxiety resulting from this incident. Patients can be confident that their tests are being completed in an appropriate manner with cleaned and sterilized equipment.”

A national review panel assessed 84 drugs for “clinical benefit, survival and quality of life, the toxicity and safety of the treatment, the level of unmet need and the median cost per patient. In cases where the high cost of a drug would lead to its exclusion from CDF, manufacturers were given an opportunity to reduce prices. The result of the review is that 59 of the 84 most effective currently approved indications (clinical ‘uses’) of drugs will rollover into the CDF next year, creating headroom for new drug indications that will be funded for the first time.”

The move will shave £80 million in projected outlays under the CDF in 2015, constraining its growth to £340 million in fiscal 2015/16 from £280 million in 2014/15, and thus stave off “offsetting cuts in other aspects of cancer treatment such as radiotherapy, cancer diagnoses, cancer surgery, and other important NHS services for other patient groups.”

“There were drugs that did not offer sufficient clinical benefit so we simply cannot go on funding those. There were others that offered some benefit but were costly and I am pleased that a number of pharmaceutical firms worked with us to make prices more affordable, saving millions of pounds that can now be reinvested in other treatments,” CDF chair Professor Peter Clark argued. “These are difficult decisions, but if we don’t prioritise the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline.”

Australian Health Minister Sussan Lay announced that the Liberal government was ditching its plan to reduce payments for visits to general practitioners and will enter into consultations with doctors on resolving “issues such as six minute medicine” and eliminating financial incentives that favour shorter visits with patients. The Australian Medical Association had argued that the government’s plan to reduce payments for visits to general practitioners would inevitably precipitate a run on emergency departments and create a systemic crisis similar to that now being seen in the United Kingdom because of funding cuts. ““In the UK, there has been an explosion in demand for GPs – they are seeing 120,000 more patients each day than they were five years ago – but Government funding for their services has plunged to an all-time low,” said AMA Vice President, Dr Stephen Parnis. “If people can’t get in to see their GP, they will often end up at hospital, increasing to the pressure on already-strained emergency departments and greatly adding to the Government’s health bill. … As the UK experience shows, when governments cut investment in primary health care, it means more people end up going to hospital, they are sicker, and they are much more expensive to treat. We must not go down this path.”

Five American states have already passed so-called “right-to-try” laws giving patients access to unapproved medications and at least 15 more states are expected to follow suit in 2015, although critics are concerned access to such drugs may hasten death, the New York Times reported.

United States acute care hospitals have achieved “significant reductions” in health-care associated infections (HAIs) between 2008 and 2013, though they haven’t yet achieved the targets laid out in the 2009 HAI Action Plan, the US Centers for Disease Control and Prevention states in a National and State Healthcare-Associated Infections Progress Report. “More action is needed at every level of public health and health care to improve patient safety and eliminate infections that commonly threaten hospital patients. CLABSI [central line-associated bloodstream infections) and SSI [select surgical site infections] show the greatest reduction as they closely approached the set goals. Some progress is shown in reducing both hospital-onset MRSA [methicillin-resistant Staphylococcus aureus] bacteremia and hospital-onset C. difficile infections. The Report shows an increase in CAUTI [catheter-associated urinary tract infections], similar to last year’s report, signaling a strong need for additional prevention efforts.”

United States President Barack Obama’s administration unveiled regulations to constrain the fees that non-profit hospitals charge poor and uninsured Americans to the “amounts generally billed” to those who have insurance. The uninsured are now typically billed at the top rate. The Additional Requirements for Charitable Hospitals also require nonprofit hospitals (about 60 per cent of US hospitals) to ascertain a patient’s financial status, and possibly provide financial assistance or free care, before pursuing such avenues as selling files to a debt collector, placing a lien on a patient’s home or obtaining a court order to garnishee wages.

The United Kingdom’s National Screening Committee has recommended against dementia screening of all Brits over the age of 65 on the grounds that existing treatments would do little to slow or prevent progression of the disease. “While the current test would identify people with mild cognitive impairment, many of them would not go on to actually develop dementia. The evidence shows us that for every 100 people aged 65 tested, 18 would test positive, but only 6 of these would have dementia and 1 case would be missed,” said director of programmes Dr. Anne Mackie.

The rate of investment in medical research in the United States declined significantly between 2004 and 2012, reducing America’s share of global research funding to 44 per cent from 57 per cent, while the rate in Asia, and particularly China, soared, according to a new study, The Anatomy of Medical Research: US and International Comparisons, published in JAMA. The decline indicates a need for new sources of research funding, “including repatriation of foreign capital; innovation bonds; research trusts built on investments by public and private entities, including individuals; and tax checkoffs for individuals to specify that a portion of their tax payment go to research,” argued a companion JAMA editorial, (subscription required).